Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090682
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | AB | No | No |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/24/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/08/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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05/08/2023 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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01/27/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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10/24/2014 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
08/13/2015 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
03/15/2013 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 079012 | ADAPTIS |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 090500 | APOTEX |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 090682 | AUROBINDO PHARMA |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 090216 | CHARTWELL RX |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 077135 | CIPLA |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 203047 | HETERO LABS LTD V |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 201506 | JUBILANT GENERICS |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 078518 | MYLAN PHARMS INC |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 077478 | SANDOZ |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076588 | SUN PHARM INDS LTD |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 209553 | YILING |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 079137 | ZYDUS LIFESCIENCES |
VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020487 | GLAXOSMITHKLINE |
TABLET;ORAL; EQ 1GM BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 079012 | ADAPTIS |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 090500 | APOTEX |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 090682 | AUROBINDO PHARMA |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 090216 | CHARTWELL RX |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 077135 | CIPLA |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 203047 | HETERO LABS LTD V |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 201506 | JUBILANT GENERICS |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 078518 | MYLAN PHARMS INC |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 077478 | SANDOZ |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 076588 | SUN PHARM INDS LTD |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 209553 | YILING |
VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 079137 | ZYDUS LIFESCIENCES |
VALTREX | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET;ORAL | Prescription | Yes | AB | 020487 | GLAXOSMITHKLINE |